FDA.reportPublic FDA data

Lingual Molar Sheath

Primary DI
00192029041055
Brand
Lingual Molar Sheath
Company
TP ORTHODONTICS INC
Model
328-254L
Device description
Distal Ball Hook Upper Left
Published
2021-03-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
DZDTUBE, ORTHODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZDTube, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00192029041055PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192029041055001920290410551920290410550192029041055

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic tubeA device used in orthodontics to attach a wire(s) or headgear to orthodontic bands bonded to the teeth. It is typically welded to an orthodontic band or bonded to a tooth. This is a single-patient device that is used for the duration of the treatment (single-use) before being discarded.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
005432299
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00192029043264Foam Pellets150-7052023-10-05
00192029043271Bonding Accessories150-7142023-10-05
00192029043288Bonding Accessories150-9042023-10-05
00192029000199Light Cure Adhesive151-2722022-02-01
00192029000205Bonding Accessories150-0152022-02-01
00192029000212Bonding Accessories150-0202022-02-01
00192029000236Bonding Accessories150-7122022-02-01
00192029000250Bonding Accessories150-7152022-02-01
00192029000267Bonding Accessories150-8102022-02-01
00192029000083Light Cure Adhesive151-2702019-02-13
00192029000090Light Cure Adhesive151-2712019-02-13
00192029000106Light Cure Adhesive151-2732019-02-13
00192029050538Tip-Edge PLUS Stainless Steel Brackets296-61122025-02-04
00192029050545Tip-Edge PLUS Stainless Steel Brackets296-61222025-02-04
00192029050552Tip-Edge PLUS Stainless Steel Brackets296-61322025-02-04
00192029050569Tip-Edge PLUS Stainless Steel Brackets296-61422025-02-04
00192029050576Tip-Edge PLUS Stainless Steel Brackets296-61522025-02-04
00192029050583Tip-Edge PLUS Stainless Steel Brackets296-61622025-02-04
00192029050590Tip-Edge PLUS Stainless Steel Brackets296-61722025-02-04
00192029050606Tip-Edge PLUS Stainless Steel Brackets296-61822025-02-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07908611204158ICERAM CERAMIC BUTTON FOR BONDING - 2UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZD2026-05-26
07908611204172ICERAM CERAMIC BUTTON FOR BONDING - 10 UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZD2026-05-26
07908611207715BONDING TUBE MJANSON MBT 0,022 -SINGLE/N CONVERTIBLE U67R (16/17) - 10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZD2026-05-26
07908611207722MINI BONDING TUBE MJANSON MBT 0.022 – SINGLE / N CONVERTIBLE U7R (17) -10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZD2026-05-26
07908611207739BONDING TUBE MJANSON MBT 0,022 - SINGLE/N CONVERTIBLE U67L (26/27) - 10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZD2026-05-26
07908611207746MINI BONDING TUBE MJANSON MBT 0.022 – SINGLE / N CONVERTIBLE U7L (27) -10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZD2026-05-26
07908611207753BONDING TUBE MJANSON MBT 0,022 - SINGLE/N CONVERTIBLE L67L (36/37) - 10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZD2026-05-26
07908611207760MINI BONDING TUBE MJANSON MBT 0.022 – SINGLE / N CONVERTIBLE L7L (37) -10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZD2026-05-26
07908611207777BONDING TUBE MJANSON MBT 0,022 - SINGLE/N CONVERTIBLE L67R (46/47) - 10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZD2026-05-26
07908611207784MINI BONDING TUBE MJANSON MBT 0.022 – SINGLE / N CONVERTIBLE L7R (47) -10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZD2026-05-26
07908611207791BONDING TUBE MJANSON MBT 0,022 - SINGLE/CONVERTIBLE U6R (16) - 10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZD2026-05-26
07908611207807BONDING TUBE MJANSON MBT 0,022 - SINGLE/CONVERTIBLE U6L (26) - 10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZD2026-05-26
07908611207814BONDING TUBE MJANSON MBT 0,022 - SINGLE/CONVERTIBLE L6L (36) - 10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZD2026-05-26
07908611207821BONDING TUBE MJANSON MBT 0,022 - SINGLE/CONVERTIBLE L6R (46) - 10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZD2026-05-26
07908611207838MINI TUBE UNIVERSAL MJANSON MBT 0.022 - BONDING - 10UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZD2026-05-26
07908611207999KIT BONDING TUBES ADVANCED MBT 0.022 - 200UNORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDADZD2026-05-26
00190746197116Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197123Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197130Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197147Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197154Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197161Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197178Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197185Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197192Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197208Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197215Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197222Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197239Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197246Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23